US herbal tea ingredient compliance GRAS

US Herbal Tea Ingredient Compliance: Which Botanicals Can Go in a Conventional-Food Tea?

US herbal tea ingredient compliance GRAS

Most private label tea projects for the US market arrive with a wish-list formula: a sleep blend with ashwagandha and valerian, a focus blend with ginkgo and guayusa, a “glow” tea with edible gold dust. Before we quote, we check each ingredient against one question: does it have a recognised legal basis for use in a conventional food sold in the United States?

This article explains how we run that check, which common ingredients have a clear basis, which are limited to a specific form or use level, and which we ask buyers to replace. It is written for brand owners and sourcing teams, not lawyers, and it is not legal advice. Your importer of record and your own regulatory counsel make the final call.

Conventional food or dietary supplement — decide first

Conventional food vs dietary supplement tea

In the US, a tea bag can be sold under two different frameworks, and the ingredient rules are not the same.

  • Conventional food. A tea bag brewed and drunk as a beverage is a food. Each ingredient needs a legal basis: an approved food additive regulation, GRAS status (Generally Recognized as Safe), a prior-sanctioned use, or, for colours, a listed colour additive. Conventional foods may carry certain structure/function statements, but wording that implies treating or preventing a condition is a drug claim. This is the route most private label tea brands take, and it is the route our manufacturing partners are licensed for.
  • Dietary supplement. A product labelled with a Supplement Facts panel follows dietary ingredient rules instead (21 CFR Part 111 manufacturing; New Dietary Ingredient notification for ingredients not marketed before 1994). It must be made in a Part 111-compliant facility. Our food-licensed tea workshops are not Part 111 facilities, so we do not manufacture finished dietary supplements.

The wording planned for the box decides a lot. We ask buyers to send the intended claims together with the formula, because the two are reviewed together.

US herbal tea GRAS regulatory pathways

There is no single “approved herbs for tea” list in the US. The routes are:

  1. Listed in 21 CFR 182.10 — spices and natural seasonings that FDA lists as GRAS. Chamomile, peppermint, ginger, lemon balm and elder flowers are examples. The listing names a species and, often, a plant part.
  2. Listed in 21 CFR 182.20 — essential oils, oleoresins and natural extractives. Hops, rose and maté appear here as extractives. This listing does not by itself cover the dried whole plant used as a tea ingredient.
  3. Listed in 21 CFR 172.510 — natural flavoring substances, used at the minimum level needed for a flavoring effect. Valerian root, passion flower and hibiscus (roselle) flowers are listed. Some entries carry restrictions: linden leaves and elder tree leaves are listed for alcoholic beverages only.
  4. A GRAS regulation with use limits — for example, licorice under 21 CFR 184.1408.
  5. A GRAS notice filed with FDA that received a “no questions” letter, or a self-determined GRAS conclusion held by an ingredient manufacturer. Either covers a specific substance, made by a specific process, for specific uses and levels — not the botanical in general. A “no questions” letter is not an FDA approval.
  6. Common use in food before 1 January 1958 (21 CFR 170.30). Where that history is mainly outside the US, it has to be documented from published sources with independent corroboration. The fact that a product is on sale in the US is not proof. Many traditional Chinese tea ingredients fall here, and China’s food-medicine homology list has no status in US law.

What is changing in 2026

Two developments this year make the check more important, not less.

  • FDA’s proposed GRAS rule (August 2026). FDA has proposed making GRAS notification mandatory. Under the proposal, a company that has self-determined an ingredient to be GRAS would have to notify FDA before marketing it, with streamlined submissions for substances already covered by a regulation, a “no questions” letter, or pre-1958 food use. Comments close on 9 December 2026, and mandatory notifications would start 18 months after a final rule takes effect. For tea brands, the practical effect is that “our supplier says it is self-affirmed GRAS” will carry less weight, and the paper trail behind each ingredient will be asked for more often.
  • Enforcement on ashwagandha in food. In September 2026 a US tea company recalled three loose-leaf teas because they contained ashwagandha root, which FDA treated as an unsafe food additive in a conventional food. It is the clearest signal so far that “it is common in supplements” does not carry over to tea.

Ingredient-by-ingredient check

Herbal tea ingredient compliance examples

The table covers the ingredients that appear most often in US private label tea requests we receive. “Basis” is our reading of the public record for conventional food use; each buyer should confirm with their own counsel.

What this looks like on a real project

Herbal tea formula compliance review

A US brand sent us a four-blend concept: energy (guayusa 25%), focus (ginkgo 10%), calm (ashwagandha 12%, licorice) and sleep, plus a gold luster finish. Run through the table, the changes were:

IngredientBasis for US conventional-food teaWhat we tell buyers
Chamomile flowersGRAS, 21 CFR 182.10 (named species)Clear basis. Standard base for calming blends; specify the listed species.
Lemon balm, peppermint, ginger, elder flowersGRAS, 21 CFR 182.10Clear basis. Check the listed species and plant part match what is supplied.
Hops, rose, yerba mateListed in 21 CFR 182.20 as essential oils / extractives onlyThe listing covers extracts, not the dried leaf or flower in a tea bag. Whole-plant use rests on history-of-use documentation the buyer’s counsel has to establish. Yerba mate is an imported raw material with limited small-lot availability in China.
Valerian rootNatural flavoring, 21 CFR 172.510Basis exists for flavoring-level use only. European Pharmacopoeia grade must be imported; not a Chinese stock herb.
Passion flowerNatural flavoring, 21 CFR 172.510Same as valerian: flavoring-level use, imported.
Hibiscus / roselle flowersNatural flavoring, 21 CFR 172.510Basis exists at flavoring-type levels; widely used in US teas. Chinese stock item.
Linden flowers / leavesLinden flowers in 182.10; linden leaves in 172.510 are for alcoholic beverages onlySpecify flowers, not leaves.
Licorice rootGRAS with limits, 21 CFR 184.1408: glycyrrhizin not more than 0.15% in nonalcoholic beverages and in herbs & seasonings, as servedThe limit is on glycyrrhizin in the finished beverage, not on the percentage of root in the blend, and glycyrrhizin content of raw licorice varies by lot. Meeting it needs a raw-material specification or test that the buyer defines. Chinese licorice is also subject to export licensing.
L-theanine“No questions” GRAS notices GRN 209 and GRN 338 at up to 250 mg per serving, each for the notifier’s own substance, process and usesA notice is not a licence for every supplier’s L-theanine. The buyer nominates the source and holds the documentation showing the material matches a notified substance and use.
Guayusa leafGuayusa leaf hydroethanolic extract has a “no questions” GRAS notice (GRN 870, 2020) for beverages; the dried leaf is not covered by that noticeA basis exists for the extract, not the tea leaf. Supply is the harder problem: guayusa grows in the Amazon (Ecuador, Colombia, Peru) and is not stocked in China. We recommend tea leaf as the caffeine source.
Ashwagandha rootNo GRAS regulation and no GRAS notice on file. FDA has treated ashwagandha in conventional foods, including tea, as an unsafe food additive (2026 recall). A self-determined GRAS exists for one branded extract; FDA has not reviewed itWe do not accept ashwagandha in food-route teas. It stays on the supplement-route list.
Ginkgo biloba leafFDA’s 2012 scientific memorandum finds no basis to consider ginkgo biloba extract GRAS in conventional food, citing NTP carcinogenicity findings; no GRAS basis is on record for the dried leaf eitherOur policy: no ginkgo in food-route teas, leaf or extract. Remove, or move the product to the supplement route.
Edible gold / pearl luster dustMica-based pearlescent pigments are permitted only in listed foods (cereals, confections, candies, gum, certain alcoholic drinks and cocktail mixers) under 21 CFR 73.350; tea and dry beverage mixes are not listed. Metallic gold is not a listed US food colourRemove. Visual effect can come from whole flowers (rose, chrysanthemum, osmanthus, butterfly pea) instead — each checked as an ingredient in its own right.
Dried orange peel (chen pi)Citrus peel appears in 182.20 as an extractive; the dried whole peel as a food ingredient rests on history of useCommonly used; buyer’s counsel confirms the basis for whole peel. We supply species and processing details.
Jujube, goji, chrysanthemum, osmanthusNot on the 182 or 172 lists. Any GRAS basis has to be built on documented common food use before 1958 (21 CFR 170.30); presence on the US market does not establish itWidely used in US-sold teas, but we hold no GRAS documentation for them. We supply species, plant part, origin, processing and serving weight so the buyer’s counsel can assess each one. Chrysanthemum in particular is species- and preparation-specific.
Jujube seed (suan zao ren), poria, other homology-list herbsChinese homology-list status only; no US recordCase by case. We say so plainly and offer a 182.10-based alternative for comparison.
  • Guayusa — no Chinese supply; replaced with green tea.
  • Ginkgo — removed; the focus blend was rebuilt on tea leaf, peppermint and rosemary.
  • Ashwagandha — removed from the food-route version; the buyer kept it on a list for a possible later supplement line.
  • Licorice — kept at a small inclusion, with the buyer asked to set a glycyrrhizin specification for the raw material so the finished-beverage limit can be checked.
  • Gold luster — replaced with whole rose petals and butterfly pea flower.
  • Sleep — the buyer asked for supporting documents. We gave the honest answer: our jujube-seed and poria version rests on Chinese food-medicine homology status, with no US documentation; alongside it we drafted a chamomile, lemon balm and hops version so the buyer could compare the paper trail for each.

The full custom-formula process, including sampling rounds and small first runs, is described in our guide to custom branded tea bags in small batches.

When an ingredient does not pass: the three routes buyers take

Three routes when herbal ingredient does not pass

In our experience the decision is rarely “drop the product”. It is one of three moves.

  1. Reformulate on listed ingredients. The most common route. The brand keeps the positioning (calm, focus, sleep) and rebuilds the blend on 182.10 and 172.510 botanicals plus tea leaf. Taste and colour usually survive; the marketing story is rewritten around the new ingredients rather than the removed one.
  2. Split the line. The food-route teas launch first with compliant formulas, and the one or two “hero” ingredients that only work as supplements are parked for a later supplement SKU made by a US Part 111 co-packer. This keeps the launch on schedule and keeps the tea and supplement paperwork separate.
  3. Keep the ingredient and build the file. For a botanical with genuine pre-1958 food history outside the US, the brand’s counsel assembles the 170.30 documentation. This is slow and costs money, so brands only do it for an ingredient that defines the product. We support it with species, part, origin and processing details, not with a GRAS opinion.

Whichever route is chosen, the decision is made before sampling starts. Changing an ingredient after the packaging artwork is approved means new artwork, new labels and, often, a new sample round.

What to send for an ingredient check

Before we can run the table on your formula we need, per ingredient:

  • botanical name (genus and species) and plant part
  • form: whole, cut, powder or extract; if extract, the solvent and ratio
  • percentage of the blend and grams per serving
  • the route you intend (conventional food or dietary supplement)
  • the exact wording planned for the front and back of the box

With those five items an initial check takes a few working days and comes back as a marked-up version of your formula — clear basis, limited basis, or replace — with the reasoning for each line.

What we provide, and what we do not

We provide: botanical species, plant part, origin, processing method and serving weight per bag for every ingredient; a candid note on each ingredient’s regulatory footing; and, once the project scope is agreed, batch documentation and testing confirmed per project — see testing and documents for herbal tea ingredients by destination market.

We do not provide: GRAS assessments, FDA “approval” of a formula, or a claim that a Chinese food-medicine homology list entry equals US food status. Where an ingredient needs its own GRAS documentation, the buyer nominates the supplier and holds that file. For more on how the Chinese list works and where it stops, see Chinese herbs that are food grade in China: the homology list.

Frequently asked questions

Is a herb on China’s food-medicine homology list automatically legal in a US tea?
No. The Chinese list decides what can be sold as ordinary food in China. US status depends on the 182 or 172 lists, a GRAS regulation, a GRAS notice, or documented common use in food before 1958.

Can we keep ashwagandha or ginkgo if we make no health claims?
Claims and ingredient status are separate tests. Removing the claim keeps the product a conventional food, but each ingredient still needs a legal basis for that food. FDA has treated ashwagandha in tea as an unsafe food additive, and has found no GRAS basis for ginkgo extract.

Can you make the same blend as a dietary supplement instead?
Not as a finished product; our tea workshops are food-licensed, not 21 CFR Part 111 facilities. We can discuss supplying bulk herbs to a US Part 111 co-packer.

Do you test to US standards?
Test scope is confirmed per project against the destination market. Destination-specific panels, including California Proposition 65 lead testing, are quoted separately through third-party laboratories.

What should we send to get an ingredient check before quoting?
The full ingredient list with percentages, target serving weight, the route you intend (conventional food or supplement), and the wording you plan to print on the box. Send it through our private label herbal tea bags page.